by Carey Gillam
Monsanto has been steadfast in denying any such dangers or allegations of lax research. Still, the company announced in 2016 that it would transition away from tallow amine in its products, saying the decision was due to “political debate,” not any valid health concerns.26 Monsanto’s move came after European regulators started moving to ban POEA from glyphosate-based products.
Monsanto has long argued it has science on its side—that glyphosate has been proven safe and does not cause cancer and that there are no hidden dangers in Roundup’s full package of ingredients. Regulators in the United States and numerous other countries have largely agreed with those safety assurances, and the company can point to a stack of research to back up its claims. More than 800 studies demonstrate glyphosate safety, the company says.27 But critics are quick to point out that Monsanto’s money helped fund a number of those studies, and some authors had consulting arrangements with the company. And it is notable, the critics say, that regulators have relied heavily on Monsanto-supplied studies when evaluating safety. Even research that might appear to be independent often is not. One of Monsanto’s most touted studies,28 which was published in 2000 and presented to the EPA and other regulatory bodies, appeared to be authored only by three scientists from outside the company. The paper appeared to be an independent review of research on glyphosate as well as POEA used in Roundup formulations and of the breakdown product aminomethylphosphonic acid (AMPA) and ultimately concluded that a thorough assessment proved there was nothing to fear. Not only was glyphosate not a carcinogen, but the researchers declared, “Roundup herbicide does not pose a health risk to humans.” That research paper has been cited by hundreds of other publications. But the internal company documents that came to light in the Roundup lawsuits indicated that Monsanto scientists actually wrote that study. One Monsanto executive told colleagues in a February 2015 e-mail that they could “ghost-write” research materials and have certain independent scientists from outside the company “just edit & sign their names so to speak,” just as they had done with the 2000 study.29 The revelations outraged the plaintiffs. “Monsanto’s ghostwriting has infected the scientific literature,” plaintiffs’ attorneys stated in court filings. “Monsanto is often the puppetmaster behind scientific articles that are positive for the company, as well as U.S. EPA deliberations and reports.”30
Separate internal Monsanto records were almost equally unsettling, revealing company executives expressing dissatisfaction with a scientist who the company had asked to look at genotoxicity issues and who had come back with a list of concerns. If a substance is genotoxic, it can have a destructive effect on a cell’s genetic material, its DNA, causing mutations. But internal e-mails from 1999 show company executives were unwilling to do the studies the scientist suggested needed to be done. Monsanto officials instead discussed a need to find someone else who might provide a more favorable view. The records also revealed discussions of seeking out “highly credible” scientists who could be paid for work to represent the safety of Monsanto products to regulators and fend off a “growing number of questionable genotoxicity publications.”31 The e-mails indicate that such scientists were recruited, and one key result was published research that shot down concerns about genotoxicity with glyphosate.32
After the internal communications became public, Monsanto argued that the records were taken out of context and did not accurately reflect company actions. The company insisted it did no ghostwriting, but rather only provided support and information to the authors of certain papers. But skeptics see the company documents as undermining the very foundation that regulators have used to vouch for Roundup’s safety. Calls have come from the United States and Europe for regulators to throw out what appear to be tainted studies. “Monsanto tells us that Roundup is safe because scientists say it is safe. But apparently scientists sign their names, while Monsanto signs the checks. This calls into question multiple studies,” said Kara Cook-Schultz of the United States Public Interest Research Group, based in Washington, DC.33
Monsanto insists that no other pesticide has been more extensively tested than glyphosate. Its safety has been proven in evaluations that span four decades, the company states. But while independent research that shows cause for alarm has been published for all to see, the company’s own internal studies, which Monsanto says prove safety, are not available for public scrutiny because they are considered trade secrets. The ones that I’ve obtained make it clear that public scrutiny is not welcomed—each page is stamped with the warning “Contains Trade Secret or Otherwise Confidential Information of Monsanto Company.” The EPA reinforces that message, warning anyone who obtains the studies that they are proprietary and cannot be posted or released for public viewing. Some of the research, which was presented years ago to the EPA, shows that test animals exposed to glyphosate did develop tumors or other irregularities, but those anomalies were judged by the researchers to be unrelated to the chemical exposure.
“Regulatory and scientific authorities worldwide have concluded that glyphosate when used according to label directions does not pose an unreasonable risk to human health, the environment or non-target animals and plants,” Monsanto states.34 But despite the company’s assurances, over the past several years the body of publicly available research contradicting Monsanto has grown, making it hard to know just how dangerous this chemical agent could really be.
U.S. health officials have been trying for years to better understand not only glyphosate’s impacts on farmers’ health but also how the range of chemicals used in farming affects farmers and their families. Their primary research effort is a government-funded project known as the Agricultural Health Study (AHS). This massive collection of research data was launched in 1993 with funding from the National Cancer Institute and the National Institute of Environmental Health Sciences in collaboration with both the EPA and the National Institute for Occupational Safety and Health (NIOSH). The project looks at any connections between the many pesticides farmers spray on their fields and the higher rates of disease many farm communities seem to experience. The government has ample research suggesting higher rates of leukemia, myeloma, non-Hodgkin lymphoma, and cancers of the lip, stomach, skin, brain, and prostate for farmers when compared with people in more urban areas, but it hopes to use the AHS to determine more specifically just how significant the risks are and what may be done to lower those risks. More than 55,000 farmers and another 30,000-plus spouses are enrolled in the study, all from either Iowa or North Carolina, two top farming states chosen for the data gathering. From time to time, the participants get updates from the AHS researchers notifying them of new findings. They’ve been told, for instance, that a commonly used farm insecticide called diazinon is associated with an increased risk of ovarian cancer, and another widely used bug killer called malathion has been associated with an increased risk of thyroid cancer.
The study also has looked at the pesticide residues that invade farmers’ homes. In a 2007 report, for instance, AHS researchers told the farm families that they had found residues of five different pesticides in carpet dust from their homes. The pesticide found at the highest levels of the five was glyphosate.
The study is still ongoing but has thus far found little or no connection between glyphosate and disease, including NHL. One 2005 AHS study of “glyphosate-exposed” farmers did suggest an “association” with multiple myeloma that researchers said should be followed up on.35 Otherwise, the AHS data favor glyphosate safety, according to many scientists. But even that is the subject of some debate. Other scientists argue that government researchers looking at NHL cases have not yet followed farmers long enough to get a solid base of information on a disease that can take decades to develop. Several other studies looking at glyphosate and different types of cancer, such as brain and breast cancers, also show no connection.
For the average individual, reading through scientific research can be daunting, not to mention confusing. Different testing methodologies can lead to differen
t results, and those results can often be interpreted in different ways. The scientific community relies not on one study, or two, but often on many dozens or hundreds of studies before it reaches a consensus. Many studies conclude not with definitive answers but with findings that add to a building body of knowledge.
Research about glyphosate’s impacts has been drawing the attention of regulators, lawmakers, environmentalists, and consumers for years. In fact, the worrisome tumors found in rats and the other health issues researchers linked to glyphosate helped fuel efforts by U.S. consumer groups to force labeling of foods made with genetically engineered crops, because of the residues left after the crops are sprayed directly with glyphosate. But the general public did not take much notice of glyphosate until cancer experts with the World Health Organization’s International Agency for Research on Cancer (IARC) stepped into the debate in March 2015.
The scientists who gathered in Lyon, France, on March 3, 2015, for a weeklong series of discussions about glyphosate did not expect the firestorm they were about to ignite. IARC does not aim to regulate substances but rather to identify things that can cause people to get cancer. The goal is to determine where hazards exist to inform individuals and to help regulators in efforts to protect public health. To that end, IARC pulls together different scientists from different specialties and different countries on a regular basis to look at various chemicals, drugs, mixtures, occupational exposures, and even lifestyles and personal habits. These IARC working groups have evaluated about 1,000 agents since 1971.
The group asked to evaluate glyphosate was made up of seventeen scientists from eleven countries. Along with glyphosate, they were also charged with analyzing research compiled on four other pesticides. Make no mistake: these were no amateurs. The scientists assembled were among the elite, roundly seen as independent experts, pulled from top institutions around the world. Frank Le Curieux, senior scientific officer at the European Chemicals Agency in Helsinki, Finland, and an expert in toxicology, was part of the team. So was French scientist Isabelle Baldi, who holds a doctorate in epidemiology, with a research specialty in environmental toxicology, and works as assistant professor in occupational epidemiology and public health at the University of Bordeaux. Another scientist on the team was Francesco Forastiere, head of occupational epidemiology at the Lazio Regional Health Service in Italy. Experts also came from Australia, New Zealand, Canada, the Netherlands, and Nicaragua. Five came from the United States, including Matthew Martin, a biologist and rising star with the EPA’s National Center for Computational Toxicology, who has received numerous awards for his work with toxicity data.
And Aaron Blair, a scientist emeritus at the National Cancer Institute, served as chairman of the IARC team. Blair seemed the ideal candidate to lead the group—he had specialty knowledge in research that focused on evaluating cancer and other disease risks associated with agricultural exposures as well as chemicals in the workplace and the general environment. And he had a long career of accolades and appointments that acknowledged his expertise. After receiving his doctorate in genetics from North Carolina State University and a master of public health degree in epidemiology from the University of North Carolina, Blair joined the National Cancer Institute in 1976 and soon was named head of the Occupational Studies unit. He has received numerous awards over his career and has served on many national and international scientific review groups, including for the EPA. He has also authored more than 450 publications on occupational and environmental causes of cancer.
When he was named to lead IARC’s working group, Blair had no reservations about taking on the glyphosate assignment. Industry players always take an interest when chemicals they profit from are up for IARC scrutiny, as they should. But Blair never expected that examining research would make him a target of Monsanto’s ire. He would come to learn how wrong he was.
When the IARC team began its assessment, it was not charged with doing new research but rather with reviewing research already conducted, trying to determine how the various findings added up. IARC’s process is typically tedious, to say the least. The assembling of relevant data generally begins several months before the working groups meet in person, and then the members generally spend long days in conference rooms analyzing data in subgroups, writing reports, and reviewing observations at the end of each day. The working group for glyphosate was no different. The members studiously analyzed older research as well as more recent studies, weighing the methods used, the consistency of results, and the levels of adherence to research standards. There were numerous animal studies to pore over, but fewer that looked directly at glyphosate’s connections to health problems in humans.
For that latter category, the team gave particular consideration to major studies out of Sweden, Canada, and the United States.36 The group determined that the best research showed a distinct association between non-Hodgkin lymphoma (NHL) and glyphosate. The team also noted that glyphosate was linked to multiple myeloma in three studies; however, the evidence for that disease was not as strong as the evidence tying glyphosate to NHL.
The team also evaluated several studies that showed animals developed rare kidney tumors and other health problems after exposure. The studies combined to provide “sufficient evidence” of glyphosate’s carcinogenicity in laboratory animals, the IARC team found. On top of that, the IARC team concluded that there was strong evidence of genotoxicity and oxidative stress from glyphosate, including findings of chromosomal damage in the blood cells of people after glyphosate formulations were sprayed nearby.37
Overall, IARC concluded that there was “limited evidence” that glyphosate can cause cancer in humans and “sufficient evidence” that glyphosate can cause cancer in laboratory animals. The conclusion would have been for “sufficient” evidence of cancer problems for humans but for the Agricultural Health Study work done by the U.S. government that did not show definitive connections between cancer and glyphosate, Forastiere, the working group member from Italy, told me. “The evidence was mixed on humans,” he said.38
Under the classification system set up by IARC,39 the group had five options—it could deem a substance “probably not” carcinogenic to humans; “not classifiable as to its carcinogenicity” to humans; “possibly” carcinogenic to humans; “probably carcinogenic” to humans; or the most definitive—“carcinogenic to humans.” For a substance to be declared carcinogenic, the highest hazard level, there had to be “sufficient evidence” of cancer in humans or other similarly strong evidence. For the second rung, “probably carcinogenic,” which was where glyphosate landed, scientists must find at least limited evidence of cancer ties in humans and sufficient evidence in animals. The team ultimately decided the weight of the evidence was not strong enough to put glyphosate in the most worrisome category, but it was more than enough to place it just below that. A Monsanto representative sat in on the deliberations and was given the opportunity to provide input but had no vote in the outcome.
“This chemical is a probable human carcinogen by any reasonable definition,” said Christopher Portier, a toxicologist who was a nonvoting “invited specialist” to the IARC working group’s work on glyphosate. “It is nonsense to say otherwise.”40 Portier was retired by that time, living in a remote village in Switzerland. But before his retirement, he had led the National Center for Environmental Health/Agency for Toxic Substances and Disease Registry at the Centers for Disease Control and Prevention (CDC), part of the U.S. Department of Health and Human Services. Prior to that role, Portier spent thirty-two years with the National Institute of Environmental Health Sciences (NIEHS), where he served as associate director, and director of the Environmental Toxicology Program, which has since merged into the institute’s National Toxicology Program. His experience and high level of expertise had earned him credibility around the global scientific community. But critics of the glyphosate decision were quick to seize on the fact that in his retirement, Portier did some part-time consulting work with the Environmental
Defense Fund, a nonprofit advocacy group. Portier’s affiliation with the group, whose mission is “to preserve the natural systems on which all life depends,” meant he was too biased to weigh in on glyphosate, industry advocates charged. Even though Portier did not vote on the IARC classification, his presence should be enough to discredit the findings, the industry players argued.
But Portier, Blair, Forastiere, and the other IARC scientists said they were more than comfortable with the validity of their work and proud of the thoroughness of what was a complicated undertaking. In a full report on the findings, the group underscored why the work matters. They cited research showing glyphosate can be found in soil, air, surface water, and groundwater and also cited studies showing glyphosate residues were easily found in food, including detections in 50 percent of cereal samples tested in Denmark and in six out of eight samples of tofu made from Brazilian soy. They also looked at data that showed glyphosate concentrations found in human urine, both in urban populations in Europe and in a rural population living near areas sprayed with glyphosate in Colombia.
“We knew that any determination from IARC would have been important because we knew the product was widespread and there was a lot of interest,” Forastiere said.